FDA.report

Marina Medical

Primary DI
00840306828140
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
300-199
Catalog number
300-199
Device description
Silicone Mat for Sterilization Tray, Autoclavable, fits 7x11 tray
Published
2024-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LRPTRAY, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840306828140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306828140008403068281408403068281400840306828140

GMDN Terms

TermDefinition
Surgical tray standA mobile, freestanding device intended to be used during a surgical procedure onto/into which a surgical tray (e.g., surgical sponge-counting tray) can be placed. It consists of a metal vertical upright on a wheeled base with a top surface that may allow for integration of dedicated surgical trays. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(954)924-4419enrico@marinamedical.com
+1(954)924-4418enrico@marinamedical.com

Regulatory Flags

DUNS number
011442279
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00840306830945Marina Medical20-017420-01742025-03-12
00840306836466Marina Medical200-262200-2622025-03-07

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